This page includes the latest FDA filings for T2 Biosystems Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
USA | NASDAQ | TTOO | DUNS 803126320 |
Registration Number | 3010097867 |
FEI Number | 3010097867 |
Name | T2 BIOSYSTEMS, INC. |
Owner & Operator | T2 Biosystems, Inc. |
Contact Address | 101 Hartwell Avenue Lexington MA 02421 US |
Official Correspondent |
|
Registration Status | 1 |
Initial Importer | N |
Registration Expiration | 2020-04-25 |
Registration Address | 101 Hartwell Ave Lexington, MA 02421 US |
Establishment Type | Complaint File Establishment per 21 CFR 820.198 |
Device Company | Device | Date |
---|---|---|
T2 BIOSYSTEMS, INC. | T2Candida® Reagent Trays | 2024-09-19 |
T2 BIOSYSTEMS, INC. | T2Bacteria® QCheck Positive Kit | 2024-02-28 |
T2 BIOSYSTEMS, INC. | T2Bacteria® Reagent Trays | 2024-02-28 |
T2 BIOSYSTEMS, INC. | T2Bacteria® QCheck Negative Kit | 2024-02-16 |
T2 BIOSYSTEMS, INC. | T2Biothreat® QCheck Negative Kit | 2023-11-15 |
T2 BIOSYSTEMS, INC. | T2Biothreat® QCheck Positive Kit | 2023-11-15 |
T2 BIOSYSTEMS, INC. | T2Biothreat® Reagent Trays | 2023-11-15 |
T2 BIOSYSTEMS, INC. | T2Dx® | 2022-09-16 |
T2 BIOSYSTEMS, INC. | T2Candida® Cartridge Kit | 2022-04-28 |
T2 BIOSYSTEMS, INC. | T2Bacteria® Cartridge Kit | 2020-12-21 |
T2 BIOSYSTEMS, INC. | T2Bacteria® Reagent Trays | 2020-12-21 |
T2 BIOSYSTEMS, INC. | T2Dx® QCheck Negative Kit | 2020-02-26 |
T2 BIOSYSTEMS, INC. | T2Dx® QCheck Negative Kit | 2020-02-19 |
T2 BIOSYSTEMS, INC. | T2Candida 1.1 Panel | 2018-06-22 |
T2 BIOSYSTEMS, INC. | T2Bacteria Panel | 2018-06-22 |
T2 BIOSYSTEMS, INC. | T2Bacteria Panel | 2018-06-22 |
T2 Biosystems, Inc. | T2Bacteria Panel | 2018-05-24 |
T2 Biosystems, Inc. | T2Candida 1.1 Panel | 2017-12-12 |
T2 BIOSYSTEMS, INC. | T2Dx Instrument | 2015-04-06 |
T2 BIOSYSTEMS, INC. | T2Candida Panel | 2015-04-06 |
T2 BIOSYSTEMS, INC. | T2Bacteria Panel | 2015-04-06 |
T2 BIOSYSTEMS, INC. | T2Dx Instrument | 2015-04-06 |
T2 BIOSYSTEMS, INC. | T2Candida Panel | 2015-04-06 |
T2 BIOSYSTEMS, INC. | T2Bacteria Panel | 2015-04-06 |
T2 BIOSYSTEMS, INC | T2CANDIDA AND T2DX INSTRUMENT | 2014-09-22 |
NCAGE Code | 4ZDC8 | T2 BIOSYSTEMS, INC. |
CAGE Code | 4ZDC8 | T2 BIOSYSTEMS, INC. |
S.A.M. Registration | 4ZDC8 [803126320] | T2 BIOSYSTEMS, INC. |
SEC | 0001492674 | T2 Biosystems, Inc. of DELAWARE |